BILL ANALYSIS
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|Hearing Date:April 19, 2010 |Bill No:SB |
| |971 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 971Author:Pavley
As Amended:April 7, 2010 Fiscal: Yes
SUBJECT: Genetic disease services: bleeding disorders: blood
clotting products.
SUMMARY: Establishes standards for the proper storage and delivery of
blood clotting factor, a prescribed biologic, and other related
equipment and supplies for home usage by people with hemophilia or
other bleeding disorders.
NOTE : This bill was heard in the Senate Committee on Health on April
14, 2010 and passed 9-0.
Existing law:
1) Provides for the practice of pharmacy and the licensing and
regulation of pharmacies, and pharmacists by the Board of Pharmacy
(Board) within the Department of Consumer Affairs (DCA).
2) Specifies certain requirements regarding the proper storage,
handling, dispensing, and disposal of drugs, staff training
protocols, drug and supply inventory, labeling, and maintenance of
patient confidentiality.
3) Authorizes pharmacists to administer drugs and biologics pursuant
to a prescriber's order.
4) Prohibits pharmacies from leaving, picking up from, accepting, or
delivering prescriptions to any place not licensed as a retail
pharmacy, with certain exceptions, including a patient's residence
or workplace, or a licensed health facility, as specified.
5) Creates the Holden-Moscone-Garamendi Genetically Handicapped
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Person's Program, which requires the Director of Health Services to
establish and administer a program for the medical care of persons
with genetically handicapping conditions, including hemophilia.
This bill:
1) Creates the Standards of Service for Providers of Blood Clotting
Products for Home Use Act (Act).
2) Establishes findings and declarations about bleeding disorders and
treatment for bleeding disorders.
3) Specifies that the purposes of the Act is to establish standards of
service for providers of blood clotting supplies and promoting
access to a full range of essential blood clotting products and
equipment for use at home by people with hemophilia and other
bleeding disorders.
4) Applies definitions for the purpose of this Act, specifically:
a) "Assay" as the amount of a particular constituent of a mixture
or of the biological or pharmacological potency of a drug.
b) "Ancillary infusion equipment and supplies" as the equipment
and supplies required to infuse a blood clotting product into a
human vein, including, but not limited to, syringes, needles,
sterile gauze, field pads, gloves, alcohol swabs, numbing creams,
tourniquets, medical tape, sharps or equivalent biohazard waste
containers, and cold compression packs.
c) "Bleeding disorder" as a medical condition characterized by a
deficiency or absence of one or more essential blood clotting
proteins in the human blood, often called "factors," including
all forms of hemophilia and other bleeding disorders that result
in uncontrollable bleeding or abnormal blood clotting without
treatment.
d) "Blood clotting product" as an intravenously administered
medicine manufactured from human plasma or recombinant
biotechnology techniques, approved for distribution by the
federal Food and Drug Administration (FDA), that is used for the
treatment and prevention of symptoms associated with bleeding
disorders.
e) "Consumer" as a person needing a blood clotting product for
home use.
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f) "Emergency" as a situation in which a prudent layperson could
reasonably believe that the consumer's condition requires
immediate medical attention.
g) "Hemophilia" as a human bleeding disorder caused by a
hereditary deficiency of the Factors I, II, V, VIII, IX, XI, XII,
or XIII blood clotting protein in human blood.
h) "Hemophilia treatment center" as a facility for the treatment
of bleeding disorders, including, but not limited to, hemophilia,
that receives funding from federal government sources.
i) "Hhome nursing services" as specialized nursing care provided
in the home setting to assist a patient in the reconstitution and
administration of blood clotting products
j) "Home use" as infusion or other use of a blood clotting
product in a place other than a state-recognized hemophilia
treatment center, including a home or physician's office.
aa) "Provider of blood clotting products for home use" as
including but not limited to any hospital pharmacies, health
system pharmacies, pharmacies affiliated with hemophilia
treatment centers, specialty home care pharmacies, and retail
pharmacies that provide blood clotting products and ancillary
infusion equipment for home use, and patient assistance for the
management of bleeding disorders. Allows these providers to offer
home nursing services for persons with bleeding disorders.
1)Provides that each provider of blood clotting products for home use
shall meet all of the following requirements:
a) Have sufficient knowledge and understanding of bleeding
disorders and the medical and psychological management thereof,
including, but not limited to, home therapy.
b) Have sufficient clinical experience serving people with
bleeding disorders and have sufficient non-clinical understanding
of bleeding disorders so he or she knows when patients have an
appropriate supply of clotting factor on hand and knows about
proper refrigeration of clotting factors.
c) Have knowledgeable pharmacy staff on call 24 hours a day in
the event of need to provide emergency clotting factors.
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d) Supply blood clotting products and home nursing services, as
prescribed by the consumer's treating physician, and not make any
substitutions of blood clotting products or assay amounts.
e) Ask the prescribing physician which specific blood clotting
product is intended whenever a prescription does not indicate the
specific product and then use the product named in the
physician's response.
f) Supply all brands of blood clotting products approved by the
FDA in multiple assay and vial sizes, including products
manufactured from human plasma and those manufactured with
recombinant biotechnology techniques, provided manufacturer
supply exists and payer authorization is approved.
g) Supply all necessary ancillary infusion equipment and supplies
with each prescription, as needed.
h) Maintain adequate stocks of blood clotting products and
ancillary infusion equipment and supplies.
i) Store and ship, or otherwise deliver, all blood clotting
products in conformity with all state and federally mandated
standards, including, but not limited to, the standards set forth
in the product's approved package insert.
j) When home nursing services are prescribed by the treating
physician, to offer these services either directly or through a
qualified third party with experience in infusing bleeding
disorders and coordinate pharmacy services with the third party
when one is used to provide home nursing services.
aa) Upon receiving approved authorization for a non-emergency
prescription, to ship the prescribed blood clotting products and
ancillary infusion equipment and supplies to the consumer within
two business days for established customers and three business
days for new customers.
bb) Upon receiving approved authorization to dispense a
prescription for an emergency situation, to deliver prescribed
blood products, ancillary infusion equipment and supplies,
medications, and home nursing services to the consumer within 12
hours after receipt of the prescription for patients living
within 100 miles of a major metropolitan airport, and within one
day for patients living more than 100 miles from a major
metropolitan airport.
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cc) Maintain 24-hour on call service 7 days a week for every day
of the year, adequately screen phone calls for emergencies, and
respond to all phone calls within one hour or less.
dd) Provide consumers who have ordered their products a designated
contact phone number for reporting problems with a delivery and
respond to these calls immediately.
ee) Provide patients notification of recalls and withdrawals of
blood clotting products and ancillary infusion equipment within
24 hours and requires providers to participate in the National
Patient Notification System for blood clotting product recalls.
ff) Provide language translation services, both over the phone and
in person, as needed by the consumer.
gg) Have a detailed plan for fulfilling their requirements in the
event of a natural or manmade disaster or other disruption of
normal business operations.
hh) Provide for proper collection, removal, and disposal of
hazardous waste pursuant to state and federal law, including, but
not limited to, sharps containers for the removal and disposal of
medical waste.
ii) Clearly inform a consumer of his or her copay, deductible, and
coinsurance payment responsibilities initially and when changed
by the consumer's insurance, health plan, or other third-party
payer.
jj) Provide consumers with a copy of all billing invoices.
aaa) Provide appropriate and necessary recordkeeping and
documentation as required by state and federal law and retain
copies of the patient's prescriptions.
bbb) Comply with the privacy and confidentiality requirements of
the Health Insurance Portability and Accountability Act of 1996
(HIPAA).
2)Requires the Board to enforce and administer the provisions of the
Act.
FISCAL EFFECT: Unknown. This bill is keyed "fiscal" by Legislative
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Counsel.
COMMENTS:
1. Purpose. This bill is sponsored by the Hemophilia Council of
California (Sponsor). According to the Author and Sponsor, there
are currently no standards of service in state law governing the
proper storage and delivery of blood clotting products and this
bill will protect the health of people with coagulation disorders
who use these products at home. Sponsors cite, as a need for a
state standard, a recent situation in which a Northern California
pharmacy delivered clotting factor product to a patient and left it
on their doorstep where the product subsequently spoiled in the
heat. The Author and Sponsor also note, that pharmacies and other
entities specializing in the delivery of blood clotting products
for home use form a growing segment in California and standards
will "benefit people with hemophilia and other bleeding disorders,
as well as maintain the current cost effective model for care for
future generations." The Sponsor also states that California needs
to have equal standards for all companies distributing clotting
factor in order to protect people with bleeding disorders from
companies that may not properly store or distribute clotting
factor.
2. Background. According to information provided by the Sponsors,
hemophilia is a rare, hereditary bleeding disorder affecting close
to 17,000 people in the United States, about 4,000 of whom live in
California. Von Willebrand disease, another bleeding disorder,
affects about 360,000 Californians. People born with hemophilia
have little or no clotting factor, the protein needed for normal
blood clotting. Until the 1970s, people with severe hemophilia
suffered from uncontrollable internal bleeding, orthopedic
deformities and a shortened lifespan. Recent inventions and
production of highly purified blood clotting factors have helped
give additional quality of life to those living with bleeding
diseases. Factor products on the market today are usually free
from previous risks like HIV and hepatitis as a result of
contaminated material.
Bleeding diseases are not curable but are treatable, often through
intraveneous (IV) injection or infusion of prescription blood
clotting products several times per week. A variety of blood
clotting products, produced by various pharmaceutical manufactures,
can be prescribed to temporarily replace the missing clotting
factors in order to prevent or correct bleeding episodes. To
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properly administer blood clotting factors, patients must often use
ancillary supplies and equipment, such as syringes, tourniquets,
gauze, and alcohol swabs. Blood clotting products are generally
expensive and require special handling, including storage at
certain temperatures, and sensitivity to extreme exposure to light.
The Centers for Disease Control (CDC) recommends timely access to
hemophilia treatment and the products and services related to that
treatment.
Treatment is available to people with hemophilia and others
suffering bleeding disorders at federally funded Hemophilia
Treatment Centers (HTCs) or by prescription at pharmacies licensed
in the state. The CDC reports that patients treated at HTCs
significantly reduce their morbidity and mortality. There are over
140 HTCs in the nation which provide both diagnostic and treatment
services to people with hemophilia and other bleeding disorders,
combining the efforts of physicians, nurses, social workers,
physical therapists, orthopedists and dentists to comprehensively
serve patients.
In California, many blood clotting product providers are specialty
care pharmacies. While these pharmacies may specialize in the
provision of treatments and supplies to individuals with specific
chronic diseases, they are not licensed according to different
standards than other pharmacies. Specialty pharmacies often ship
or deliver blood clotting products to the homes of individuals with
hemophilia, and other bleeding disorders, and when necessary,
provide or arrange for nursing services to patients who may need
assistance with infusion of the blood clotting products.
Various other states including California have attempted to
establish standards for blood clotting products, including
Massachusetts, Missouri, Pennsylvania and New Jersey. New Jersey
enacted that state's "Standards of Care in Hemophilia Homecare Law"
that was enacted in 2000. The primary issue was a requirement by
insurers that people with hemophilia worked with certain home care
companies with which they had contracts. The Hemophilia
Association of New Jersey found that often times, not all home care
companies were familiar with hemophilia care, needs, and
complications. New Jersey now requires all insurance carriers that
provide coverage for the home treatment of hemophilia to contract
with home care providers that comply with certain minimum standards
of care developed by their Department of Health & Senior Services,
in consultation with the Hemophilia Association.
3. Prior Similar Legislation. SB 1594 (Steinberg) of 2008 was almost
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identical to this bill. SB 1594 stemmed from conversations between
the Hemophilia Council of California and pharmacies that distribute
blood clotting products for home use. The bill was held in the
Senate Appropriations Committee.
4. Arguments in Support. The California Medical Association and
Herndon Pharmacy in Fresno state their support, noting that this
bill will ensure that all providers of blood clotting products are
subject to the same quality and service standards which will
benefit the consumer of these products.
CSL Behring , "a leader in the plasma protein therapeutics industry"
and Plasma Protein Therapeutics Association , "representing the
world's leading manufacturers of plasma-derived and recombinant
biologic therapies," write in support, noting that the standards
set forth in this measure will help ensure that people with
bleeding disorders can lead healthy and productive lives.
Grifols , another producer of biologic therapies, states that it is
important to preserve access to the full range of therapies, and it
is important that there are no regulatory barriers to obtaining
blood clotting factors.
5. Arguments in Opposition.
The California Pharmacists Association has an "Oppose Unless
Amended" position on this bill because of a number of provisions
that are "problematic for the smaller pharmacies that dispense
blood factor and other medications" to those with bleeding
diseases. "If these requirements were imposed on the smaller
pharmacies serving those with Hemophilia, most would be forced to
discontinue providing these products.
6. Senate Committee on Health amendments. The Senate Committee on
Health suggested amendments and also raised concerns that there are
ambiguities in the use of certain terms in this bill. The Author
accepted amendments in the Committee hearing to:
Further define the term "provider of blood clotting
products for home"
Clarify use of the the terms "sufficient knowledge and
understanding of bleeding disorders" and "sufficient clinical
expertise" as those terms relate to the requirements for
providers of products for bleeding disorders.
Clarify that the Board does not have to enforce the
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requirement for physicians to specify the type of clotting
product to use because the Board does not have jurisdiction
over prescribing physicians.
SUPPORT AND OPPOSITION:
Support:
Hemophilia Council of California (Sponsor)
California Medical Association
CSL Behring
Grifols
Herndon Pharmacy
Plasma Protein Therapeutics Association
Opposition:
California Pharmacists Association
Consultant:Sarah Mason